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  • IRB: ETHICS & HUMAN RESEARCH

Reaping the Bounty of Publicly Available Clinical Trial Consent Forms

Abstract: Research consent forms provide important fodder for empirical analysis but can be difficult for those not running or participating in a particular study to access. Recognizing this problem, ClinicalTrials.gov has begun accepting consent forms for public posting on a voluntary basis, and revisions to the Common Rule slated to take effect in 2018 will require that at least one consent form for each clinical trial be made publicly available. These changes will increase transparency, improve the efficiency of drafting consent materials through the provision of good and bad examples, allow stronger evidence-based practice around high-quality research consent, and permit greater ethical analysis of precisely what participants are told about the studies they enroll in. Important limits will remain, but promoting transparency around informed consent is a step in the right direction.

Keywords: research consent, evidence-based policy, ClinicalTrials.gov, Common Rule revisions, empirical research agenda